DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Guangzhou Medical University
About this trial
This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) combined with hepatic artery infusion chemotherapy (HAIC) with oxaliplatin and raltitrexed (RALOX-HAIC) versus DEB-TACE alone for unresectable large hepatocellular carcinoma (HCC).
Eligibility criteria
Qualifiers
HCC confirmed by histology/cytology or diagnosed clinically.
At least one measurable intrahepatic target lesion.
The largest tumor size > 7 cm.
Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment.
Disqualifiers
Macrovascular invasion or extrahepatic metastasis.
Diffuse HCC.
Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy.
Trial design
Treatments tested in this trial
- DEB-TACE+HAIC
- DEB-TACE
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Second Affiliated Hospital of Guangzhou Medical University
Lead sponsor
Zhongshan People's Hospital, Guangdong, China
Collaborator
Guangzhou Development District Hospital
Collaborator
The Affiliated Shunde Hospital of Jinan University
Collaborator
Source ClinicalTrials.gov